Roux-en-Y Gastric Bypass Versus Loop Gastrojejunostomy for Malignant Gastric Outlet Obstruction
Launched by SPECTRUM HEALTH HOSPITALS · Aug 3, 2023
Trial Information
Current as of July 01, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is exploring two types of surgery for patients with malignant gastric outlet obstruction, which is a condition where cancer growth blocks the normal passage of food from the stomach to the small intestine. The trial specifically compares Roux-en-Y gastric bypass surgery to a conventional method called loop gastrojejunostomy. The main goal is to find out if the Roux-en-Y surgery allows patients to eat solid foods more comfortably in the first month after the operation.
To participate in this study, individuals must be at least 18 years old and diagnosed with malignant gastric outlet obstruction, which can cause symptoms like stomach pain, nausea, and vomiting due to the blockage. Patients should be in good overall health to undergo surgery. Those who have had previous treatments for this condition or are better suited for a less invasive procedure, like a stent placement, will not be eligible. Participants can expect to receive careful monitoring and support throughout the study to evaluate their recovery and food intake following surgery.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Provision of signed and dated informed consent form.
- • 2. Stated willingness to comply with all study procedures and availability for the duration of the study.
- • 3. Male or female aged ≥18 years old.
- • 4. Patients with a diagnosis of malignant gastric outlet obstruction. i. Defined as malignant cancer growth of any organ origin in the area of the distal stomach or duodenum preventing normal gastric emptying as determined by symptoms and cross-sectional imaging studies.
- • ii. Symptoms can include abdominal distention, abdominal pain, nausea and vomiting.
- • iii. Cross sectional imaging findings can include tumor growth in the area of the distal stomach or duodenum, gastric distention, fluid filled stomach and decompressed bowel distal to obstruction point.
- • 5. Patients deemed to benefit from surgical bypass as opposed to stent placement, by the primary surgeon. This includes assessing participants survival chances and ability to undergo a surgical procedure.
- • 6. Patients in a general health status that permits abdominal surgery under general anesthesia. As determined by primary surgeon and anesthesiologist.
- Exclusion Criteria:
- • 1. Patients that have had previous treatment for malignant gastric outlet obstruction.
- • a. Including any previous surgery or stent placement for MGOO
- • 2. Patients with MGOO deemed to benefit more from endoscopic stent placement rather than surgery for symptom relief. This assessment will be at treating surgeon's discretion.
About Spectrum Health Hospitals
Spectrum Health Hospitals is a leading healthcare provider dedicated to delivering high-quality patient care and advancing medical research through innovative clinical trials. As a part of a comprehensive health system, Spectrum Health Hospitals integrates cutting-edge technology and evidence-based practices to enhance patient outcomes and contribute to the broader medical community. With a commitment to ethical standards and patient safety, Spectrum Health Hospitals actively engages in diverse clinical research initiatives, fostering collaboration among healthcare professionals, researchers, and participants to drive advancements in treatment and therapeutic options.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Grand Rapids, Michigan, United States
Patients applied
Trial Officials
G. Paul Wright, MD
Principal Investigator
Corewell Health
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported